CAPA Engineer
Core
Facilitate and execute Corrective and Preventive Action (CAPA) processes to ensure compliance, quality, and timeliness of records while supporting continuous improvement of the Quality Management System (QMS).
Role type
Quality Assurance Engineer (Medical Devices)
Builds
Safe and effective diabetes care products (blood glucose test strips and sensors) meeting regulatory standards.
Domain
Medical Devices / Diabetes Care / Manufacturing Quality
Required skills
CAPA process execution, root cause analysis, risk management, project management, data analysis, report writing, audit support, cross-functional collaboration
Preferred skills
Medical device experience, FDA QSR (21 CFR Part 820), GMP, ISO 13485:2016 knowledge
Technologies
Six Sigma methodologies, statistical analysis tools
Responsibilities
Lead or participate in CAPA projects, investigate quality issues and gather data, process and assign quality requests, present metrics and identify trends, support CAPA training programs, provide subject matter expertise during audits and inspections, support operations in quality/compliance decisions (via careerplan.io/jobs/31163525-capa-engineer-at-abbott)
Seniority
Mid-level, hands-on IC
